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tv   Key Capitol Hill Hearings  CSPAN  March 15, 2014 6:00am-8:01am EDT

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that they are clearly understood by the companies in terms of what time lines will be. and i i think no doubt it is an area where we can often be more
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efficient and responsive than we have been and we are committed to trying to do the best job possible but not knowing the specifics, i can't tell you -- i do believe i saw a letter from you that we are moving forward on sad in a relatively timely way, but i will get back to you on your specific query, and more broadly i would say over the last couple years we have been working hard to streamline and modernize our regulatory systems to address the business process issues that slows things down and recognize the importance of good communication with companies around these kinds of activities. >> i understand breakthroughs in medical science and
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pharmaceuticals and devices sometimes, the goals are used and you have to determine which one they are. >> that is true. in this arena as in many other arenas, sometimes our authorities were first established, looks very different today and that is why we had to modernize through fdasia updating the worldcom accounting pharmacy laws, etc.. and look at how our system this match the real world needs. >> appreciate your attention. my time is almost up. i will submit another question that is important with regard to fda considering regulation of medical i t and there was consideration. >> there is interest. >> we need to look at congress's responsibility as well. thank you for your service.
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>> thank you. >> i would like to thank you and the ranking member senator alexander for holding this important hearing. commissioner, welcome back. i want to take a minute before i ask this question to thank you for the fda's work over the last few years. hasn't been easy to implement a comprehensive fda reform bill while beginning the compounding bill. you came out to my home state of colorado in 2011 and listened to many people in our bioscience community all across the state who were having difficulty communicating back and forth with the fda and she made a commitment that things were going to get better and i can tell you that i have heard this from many people back home, they have seen a very positive change and a lot of that is due to your leadership. nothing is perfect but i hear consistently how much things have improved at the fda and on behalf of my constituents on
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want to saying you for that. i was pleased to see the implementation of the bills and i worked on that created the breakthrough oyster of the designation for drugs that has shown dramatic results early in the approval process. 043 received this designation. we passed that bill and its u.s. we would be sitting today with 40 drugs i would have said you are delusional but that is in fact what has happened. drugs that are trying to cure various kinds of cancers, many life-threatening conditions, i visited a number of colorado patients receding breakthroughs therapies and i can tell you it has made a life-saving difference for many who tell me their dream is only to live a normal life. that is all the want to do like everyone else, something the rest of us take for granted. as a result of this effort to get drugs to patients more efficiently we have seen a number of people writing to our
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office asking for more direct dialogue with the fda regarding crown making drugs should be considered to be breakthrough therapies, no one wants to enforce the data fda looks at and there should be an avenue for patients to inform the fda of their opinions about scott's what might be considered a breakthrough. in light of all the work fda has already done i wondered whether you could talk a little bit about the effect this new designation has had it the agency and for the industry and for patients and what you might be willing to have more open dialogue with patients to consider information they would supply with respect to break through therapy designations. apologize for the warm wind up but i am excited to see something working well and want to give you the opportunity to talk about. >> i could give you an answer. i will try to be brief. is an important exciting new opportunity for us and we appreciate that it was included
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in the legislation. it has been more popular and successful than we had anticipated. the other side of that is we actually didn't get new resources to implement this program but we have been able to identify a very large number of exciting drugs that really holds promise to treat serious, often life-threatening illnesses. we have been able to approve three products for four different indications under this breakthrough therapy half way and i think that we will continue to see it as a very important program. underscore is another set of important points that have broad ramifications for our work at the fda. one of the aspects that is successful is the early engagement with the fda review teams and senior levels scientists at the fda to really
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helped shape what is the best development strategy so that we can't ask and answer all the critical questions to address the safety and efficacy question, but actually move through the system as quickly as possible so these promising drug candidates can get to the people who need them and in that regard the opportunity for engagement of patients is critical. in another aspect of our fda work we have been also establishing a series of meetings with patients are around some critical disease areas to get their input in terms of how the disease manifests itself or condition in their lives. how we should be thinking about patient reported outcomes in many instances, this is part of our study design, and how to make sure we are helping to address critical unmet medical care needs while trying to help
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speed innovation and product development. >> my time is up but i want to thank you, mr. chairman, i want to thank you because your leadership really has made a material difference and as we see the fda exercising its muscle around this one part of the pipeline is my hope is we are going to as you are implying, be able to see across the fda as we think about how to make sure the united states maintains its leadership in bioscience going into 21st centuries a thank you. >> thank you, my thanks to you because you spearheaded that effort for couple years so i am grateful for you taking that over and running with it. appreciate it very much. >> thank you. >> senator robert.
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those of you are on that issue thinking about it. >> that use of ten seconds of my time. thank you. i would follow upon what senator warren was asking about where the animal antibiotics in wyoming and a proposed federal dairy feed director comes from a very heavily populated state. i come from sparsely populated state and when that is underserved by large animal veterinarian so we have different problems with that and in light of her one question taking up all five minute time submit that one in writing. i have worked with senator tester on the tester amendment which is food modernization act that provide specific accommodations for preventive control for small farmers and producers. what is the status of the implementation of that. >> the tester and amendment in
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particular or more broadly? one of the things as we have been doing outreach in response to developing a proposed rules and now as we are taking comments, one of the things more broad than the tester amendment is the impact on small farmers and the fact the we have a system where there are very different types of food producers and we need to find a way to ensure greater food safety but not impose undue burdens. >> i will submit that with the bill too. i heard a number of concerns from through food producers about the over the prescriptive framework when considering the preventive controls for human food. what concerns me even more it doesn't appear the fda has appeared to the requirements of the administrative procedures
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act, how it went about publicizing how those rules. can you provide this committee with a commitment that he will lead you to the requirements of the administrative rich cheeses act on for the rulemaking? >> i have not heard that concern. if anything we have done a remarkable job in terms of outreach and engagement and taking comment and responding to comments so i will -- can dachshund questions and follow a. >> we will provide more detail on that too. so from my next question, we are concerned about the abuse key turned formulations, and if the agency establishes the clear path way companies will continue to invest in this kind of research. i have heard from the drug manufacturers who are working toward that would like to adopt use deterrent formulations. they are sine die and confused by the fda's lack of clear and
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consistent standards. when you plan to finalize the guidance and can we expect the guidance to include generic versions? is in trouble in the fight for prescription drug abuse to use all the available tools and the regulatory uncertainty is slowing down to together tools and that is unacceptable so can you commit to meet to finalize the guidance in the next six months. >> the guidance is important lays out how we are thinking about it. in all honesty the science and technology needs to be developed here. we really need to incentivize companies to work hard on this, we want to provide as much clarity as possible because it is such an important area and we need to develop abuse deterrent approaches for these powerful drugs. >> there is no timetable laid out for it? >> i am not sure what the time frame is.
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we issued the guidance may be a few months ago, a year ago. so -- >> i would like a fairly extensive cancer and appreciate the efforts on it. there is a new pathway to assume biosimilars and crafting the bipartisan proposal to create a pathway and lead discussions to ratify user fees to support the program. you mentioned resources earlier and i am interested in how bose are implemented as particularly committed to insuring the implementation ins consensus driven with the original law. i am looking for a a commitment that the fda will be transparent, will issue guidance to ensure we all understand and also give the stakeholders' which would include us the opportunity to engage with the key policy questions before the
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final decisions are made. >> absolutely committed to that. we are stepping up the program as you know and we have had many discussions with companies that are developing or interested in developing biosimilars as part of that program and half way. >> thank you and i have additional questions but my time is up. thank you. >> senator casey. >> thank you very much. grateful for your presence and your good work. i wanted to try to get to lease two areas. one is on this issue of locks and --miloxin which allows doctors and others to administer the drug in the case of an overdose to reverse it. in particular, i wanted to highlight an element of
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legislation. senator you all --udall as a bill which is increasing the safety of prescription drug use, one of the provisions would ask where does ask the fda to reconsider the status of miloxin. i wanted to have you speak to that. i know you couldn't make a determination today but i would like to have you speak to that issue. in terms of its value in the context of law enforcement but more articulately as a way to deal with a crisis situation. >> miloxin is a very important medicine in terms of being able to reverse opiate overdose and certainly used on a frequent basis effectively in the health care setting. we have been concerned that many opportunities when it could save
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a life have been limited because they occur in the community, not in a health care setting and we have encouraged and reached out to manufacturers of this product to consider coming in to us with a formulation that could be provided as an auto in injector and nasal inhaler that could be more available in community settings, law-enforcement or others potentially to take advantage of this kind of formulation and could save lives so we are encouraged by the response we have had from the manufacturer and we continue to work on this important issue. >> the chairman raised this issue. a lot of people working on this, it is stunning, the numbers we have seen, the one number i keep coming back to is people who
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abuse prescription drugs on 19 times more likely to use heroin. just stunning. the state of pennsylvania is third place finish that we did not want to have in terms of heroin abuse of it is substantial and we are seeing it not in the stereotypical fashion, urban communities or places where the popular image of this kind of abuse is in big cities we are seeing in rural areas and small towns so very substantial. one more issue. the chairman also raised his hydro. if i am pronouncing that right. one issue i know the chairman raised a question of the advisory committee recommended against the approval of the product but also apparently the product was approved without any
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abuse deterrent properties, is that correct? >> that is correct. >> a related question to what the chairman asks is the concerns that number of us have a new share the concerns about the implications of allowing this new product on the market, without these abuse deterrent properties. can you speak to that? >> i would love if we had abuse deterrent formulations that were actually meaningful and effective at deterring a be used in all instances. we are moving in that direction and put out guidance for how we would be thinking about revealing and approving abuse deterrent formulations, how to demonstrate because it doesn't do any good to mabel's something as abuse that isn't abuse deterrent.
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unfortunately the technology is poor and one abuse deterrent formulation that is in the marketplace recently approved. it is abuse deterrent in terms of uses in moved sniffing. it doesn't prevent abuse or misuse when taken orally and it is an important step forward that demonstrates utility and opportunity but we need to work with the broader scientific and engineering community to come up with better abuse deterrent formulations. we are committed to working on developing non opiate pain medicines because that would make a huge difference as well. acute and chronic pain needs to
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be treated. dubya tar effective for acute pain, less effective for chronic pain. that is another commitment fda has made to develop non appeal it pain medicines that will make a difference for patients. >> i want to submit some more for the record. thank you. we will go next to senator robert. >> thank you, mr. chairman, thank you for coming. i know your time is very valuable. senator enzi question 2, the same question he asked that summed it up. i would like to go through it and your answer was yes. give that a try.
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there is concern from food industry leaders about implementation of the food safety and modernization act. specifically concerns related to prevent and control for human food proposed rule that i believe is open for comment. specifically, they are interested in the proposed rule mentioning testing and supplier verification requirements and the preamble that does not provide a specific requirement in the rule. this can get pretty expensive to say the least and there is a host of organizations which i will not go into or are very worried about this. can you assure me that you will not finalize the rule with these more prescriptive testing supplier verification requirements, the ones that are so expensive, unless they go through a full notice and comment period, regulatory process including the revised economic analysis and can you
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assure me that this will not be issued as an interim rule? >> what i can assure you is rehab from the very beginning tried to reach out to all the different stakeholders to hear their concerns, we have done lots of public meetings, visits, meetings with specific groups and individuals all trying to get input. is a complex set of rules to put forward. many different sometimes competing interests and concerns. we have gotten a lot of response, we are going to be carefully going through all the comments when different, and periods end on the rules. we may well reissue recodified language on certain key provisions because of the
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concerns you have raised. and concerns about economic impact and analyses, so we will work in a very deliberate transparent way and continue to try to drill down on these critical questions so we end up with something that will really work. >> i appreciate that. that is a long yes. anyway, i thank you for going into that. in the food and drug administration safety innovation act, we asked the gao to look at how regulations and guidance and policies and practices could be modified, streamlined, expand or discontinued in order to reduce or prevent such drug shortages. this was discussed at length with fda staff during drafting of the legislation. can you tell me whether the fda is in regards to internal review their regulations to be done to
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address instances in which the fda policies are or were meeting to drug shortages? >> a huge amount of progress has been made in the drug shortage area. certainly our team which has been expanded as well has been working long hours and diligently to address existing shortages and imminent potential shortages in this country. industry plays a critical role and the shortages that occurred generally occur because of issues with either their supply chains of products or importantly quality concerns in the manufacturing, but we have seen real improvement in the number of shortages in recent years, a fdasia has helped to strengthen progress that was made to in enabling us to
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institutionalize important ways of interacting with important activities within fda. we are moving forward and have made real progress and we have systems that are working end need to continue to be strengthened. >> i understand you are making progress and pardon the interruption. but where is your internal review, where would you say that stands now? are you have wait for real? where are we? >> i am not quite sure when you say the internal review with respect to regulations, we have delays in getting reports of to you. >> you are getting there. >> we really do think it is a
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system that is working. >> i appreciate that. before we go to senator baldwin, i want to thank senator roberts for your work on the compounding bill. now we go to -- >> thank you, mr. chairman. i appreciate that. happy to compound with you anytime. >> we go to senator baldwin. >> thank you. i want to thank chairman harkin and ranking member alexander for giving us the opportunity to ask questions of you. wisconsin is home to a vibrant community of innovative medical device companies and some interesting things going on. wisconsin innovators are making
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contributions to medical treatment with breakthrough technologies such as state of the art:cancer screening test and pioneering substance detection device. in the last several years the fda has taken on some encouraging steps to enhance patient access to devices and spur product innovation and we are very excited about some of those. in particular the fda's pilot program, a parallel review that allows the fda and cms to simultaneously review innovative devices for market approval land coverage determinations to help streamline the process for companies, the patients who are served by those innovations so the fda center for devices recently indicated that the
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agency plans on establishing a new pathway to approve devices for patients with serious unmet medical needs. under this approach as i have heard, some of the data that typically is collected in device studies could be submitted to the fda wants the devices already approved for use with patients, this proposal not only has the potential to improve treatment options but to empower smaller companies to bring new and cutting edge technologies to market by allowing them to target their resources most he efficiently and effectively throughout the approval process so i am hoping that today you could elaborate on the development of this new pathway and specifically if you could tell me how the fda will assure
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predictability for device companies. the needed evidence is collected post market in a post market setting to guaranteed patient safety. >> important question. so much exciting information on the medical device arena and the center has been working hard in a number of arenas to harness those opportunities for innovation, the innovation pathway and the entrepreneurs and residents program and looking now at how pecan learn in some ways in the drug center to tried to build in some new mechanisms set recognizing understanding safety and effectiveness and benefits to patients of a product has to be a life cycle of the product approach and as we look at the pre approval, we also have
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opportunities to deepen our understanding in real world use with post marketing surveillance and collection of data and additional studies that our continued. that has been a theme for quite a number of years and continuing now and i think that is part of the center for devices strategic plan going forward and as you noted, this approach of integrating in post market studies into the overall assessment and ongoing understanding of a device is very key and is being shaped and we will be eager to work with industry and patients and consumers and other stakeholders as it moves forward. >> we will follow this and look for more details with great interest.
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mr. chairman, i will submit additional questions for the record but thank you again for the opportunity. >> thank you. we will do that. senator mikulski. >> we appreciate all you do. there are big questions asked about fda approval of certain drugs, drug shortages, these are issues i have concerns with. in fairness to your time i want to shift to a couple subjects that have probably not been brought up and one is the shellfish ban that the chinese have imposed on shellfish coming out of parts of alaska and the west coast. this is an issue that might be very narrow in its scope and a portion of my state impacting some basically family-owned businesses that are taking up a real hit right now.
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we sent a letter on march 6th to encourage that there be at delegation to go to china to discuss this issue with the chinese to see if we can't get faster resolution of this. i understand from noaa that this meeting is guilty in china for march 21st. the u.s. delegation will include not, uh u.s. the are, and the 4 dag service, the question to you is paying you give me any assurances we are fast tracking a resolution of this issue, what fda's role is and if you will send somebody as part of this delegation and if not why not? >> this is an issue of great importance. it is something where nowak and
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the department of commerce has the league, we will be providing information and support to them as well as information about public health assessments to the chinese, to our chinese counterparts as well. we are not going to be part of the delegation but we will be in contact with him and working with them and supporting them and we have an office in china to provide additional support so we will have input but we are not in the lead. our focus is on the public health assessment. >> i appreciate that. my concern is if there are issues that arise in this meeting that speak to the specific jurisdiction of fda i would pay for things to be held -- >> we will be available to them and they will no 24 hours a day to appreciate that support. >> i would like to turn to a subject i have brought up before
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this committee. no offense to the chairman here, we often refer to this alien species of fish as the franke i frankenfi frankenfish. no offense to senator frankin. >> offense taken however. that is worse. i don't want to consume much time talking about how bad the name is. we will refer to it as genetically engineered fish and specifically salmon. you know that i have very strong concerns and reservations. i don't need to show you pictures of beautiful alaska salmon. i have them here but i will show you a picture of the eelpout where the dna is taken to this slimy ugly bottom feeding fish
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that is injected into a beautiful chinook salmon in an effort to cause these fish to grow quicker to get to a market more readily. i continue to strongly oppose, strongly oppose fda approval of genetically engineered salmon. i don't believe the fda has adequately studied the environment affects, the economic impacts not only on the wild salmon, our c food markets and potential house impacts on humans. given the concerns that i have and many others have can you assure me fda is prepared to deny approval of the sale of gee salmon to consumers if your agency determines that it cannot guarantee it is safe to eat. >> if we could guarantee that it wasn't safe to eat then it would
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not pass our approval. >> what we are looking for is we want this insurance and we don't know that it is safe to eat. we don't believe it has been determined this genetically engineered salmon would be safe to eat. we haven't been able to determine whether or not it would impact negative lee, jeopardize the while alaska salmon. i would ask again you look critically at this. the threat i believe not only to humans for consumption of this bizarre fish, the threat to our wild stocks and if in fact fda should advance to a level of approval for sale to consumers, i have been demanding that the agency provides very clear labeling to consumers, that is
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in fact what they would be purchasing for consumption and what i am seeking is a level of assurance that if it is not safe to eat it will not be out there for sale, but if it is determined that it should be allowed that there be clear labeling allowed. >> i know time is limited. complicated issue. i can assure you of a couple things. one is we have been taking a systematic science based approach to the review of this application. it does represent the first in its class so to speak so is important as a product in and of itself and also the pathway for review and approval we also undertook an environmental assessment as i think you know, and the wild salmon populations and we published in december of 2012 our preliminary findings
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sought comment, and 33,000 or 35,000 comments so this is a topic people carolina about, going through those comments, taking them very seriously. we will be moving forward in a deliberate science driven away, reflecting all the important inputs including perspectives you brought forward today and earlier as we consider this product application. >> my time has expired. i asked dr. hamburg, you and i would have an opportunity to discuss not only cheese salmon but progress we are making in other areas. i have some other questions i will submit for the record and i ask you pay particular attention to the level of inquiry about how we are doing with a al as research and the joint meetings we have been having with
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stakeholders and how we can advance. >> do any of the questions for the record include reference to a frankenfish? >> thank you, mr. chairman. >> senator hatch may be coming but i will take a round of questioning. first of all, welcome. i want to start by thanking the chairman harkin and ranking member alexander for calling this important hearings and for the leadership they have both shown regarding policy issues within fda's purview. it has been a pleasure working with both of them, reform of a number of pharmacies, pharmacy, pounding legislation, the past in november which i helped to
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develop with senator robert sack and i want to thank you, dr. hamburg, for working with us so closely on that. in your testimony you noted your quick implementation of the laws to register as outsourcing facilities, what we call outsourcing facilities already, this is a component of our bill. can you tell the committee while this was so important, how does this new option improve public health and prevent new outbreaks. >> this is targeted on high risk products, injecteds that we know can become contaminated and have very serious consequences for health. this will enable those companies that choose to register with us a higher level of assurance in
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terms of good manufacturing practice and adherence with the kind of manufacturing procedures that need to be undertaken to make these products safe. so we think this is a hugely important as i mentioned earlier. we certainly hope this company will choose to go this path way and importantly the marketplace will view this as an appropriate standard of care for the health, safety and protection of patients and health care systems will seek out those that have not just registered. that is the first step. but actually submitted applications and become outsourcing facilities and part of the program of ongoing oversight which would include regular inspections to ensure compliance with these important manufacturing procedures and
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safety protection. >> thank you for that answer. i am proud to represent minnesota where we have the culture of innovation particularly in my state's medical device industry. i spend a lot of time with start up device companies which serve as a major source of innovation within that industry and innovation for next life-saving therapies for patients. these entrepreneurs and investors are pretty tenacious and spent years doing r and d before seeing a dime of profit in hopes of improving lives. i have been doing what my device industry, and the american device industry so that is why i have been fighting the device
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taxes that were first proposed and working on the bipartisan solution to repeal the tax once and for all. i want to do everything i can to help make sure our companies which face international competition are able to succeed so in this vein, another area i have done a lot of work on is making sure the process of review is streamlined as much as possible. and fda, i have seen this, have different cultures, i have often seen the device industry talk past each other and in minnesota we had something i think is remarkable to bridge the difference between cultures and minnesota's life science alley
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which happens to be the largest state based life science trade association in the country formed a partnership that i have supported called the medical device innovation consortium and this public-private partnership is the first of its kind and its goal is to create efficiency and quality of education and its goal, it studies or talks about regulatory science and. can you tell me what progress has been made in advancing an ovation and benefiting patients because of the creation of this organization? >> thank you for the question. i felt bad that i forgot to mention it when responding to senator baldwin as an element of what is happening in the area of medical device innovation. is a public/private partnership.
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it has gotten off to a very good start. it was announced, together we launched it not too long ago and has doubled in side, 38 or so members and it spans device companies, consumer groups, patient groups, research organizations and the fda is part of it. the study created a research agenda to focus on how to advance underlying science to get a promise of science to people more quickly and focus on the number of critical areas, one, new clinical trial designs so we can ask a critical question more efficiently. hopefully also encourage more device manufacturers to do the first in the human studies in the united states rather than overseas where it is cheaper and less cumbersome, it is focused on patients reported outcomes
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and how to integrate thatch into device development which is so very important across all medical conditions and devices in particular are often and one of the things that excites me is developing computer simulations and models, in that context instead of animal models or people in the early stages so that you can number one manipulate things and play with it more but reduce costs and potential risks to patients but still really get important information, into the marketplace and making the difference in people's lives. is a wonderful public/private partnership. thank you for your leadership in helping to make it possible and we are committed to working with and we see benefits already and
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the foundation for a lot more progress. >> thank you for your role in that and your excitement and i am too, senator enzi for a second round. >> thank you, mr. chairman. i would like to revisit the goals you immediately identified when you took the helm at the fda modernizing how the agency considers new therapies closing the regulatory science gap. those goals are ones we all share. there is a continued level of frustration among patients and manufacturers the fda lags behind other countries in timeliness and today understanding of critical responsibilities including clinical trial design, valid end points for assessing the value of new therapies and how the risk evaluation and mitigation strategies are tools to protect patients and allow access to higher risk products where patients are desperate for
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treatment. senator harkin's opening statement he mentioned a case where the committee voted against a product and was overridden by the fda. i will talk about a different situation dealing with multiple sclerosis. fda made a decision to break with an overwhelming advisory committee to support the effectiveness of novel therapy for multiple sclerosis and the agency chose not to approve the drug despite its having been approved in 30 other jurisdictions based on the same data set. can you explain the logic behind the agency's decision? what did the fda see that the advisory committee could not? >> first, let me address your broader question in terms of we are at the cutting edge in terms of review and approval of new product if you look at drugs approved in recent years. three quarters of them approved
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the united states first and devices apart from the highest risk devices we are i think at par with comparable other countries in terms of review times. we do ask for more clinical data on the higher risk devices so there is some urban methodology about where we stand in comparison to review time and leadership and i would have to say the user fee program for devices and drugs have made a real difference in our ability to be as competitive as possible. with respect to the roll advisory committees and the advisory committees are very important component of the review process but they are not determinative and we seek expert advice in many ways including advisory committees which are not used with every product that
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is reviewed. sometimes it is frustrating for me when people ask about a specific product and why we didn't approve it and that is commercial confidential information we are not allowed to share without permission of the company. they take the job going through the systematic way and assessing safety, efficacy and overall risk benefits, benefit to patients and there are often things that are not obvious but make a real difference in terms of a decision that is made. >> the advisory committee -- >> very important part of our input on the decision. a majority of times the decision aligns but not always.
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>> you are saying lacking information the fda would have so they are not getting the full story? >> there are many components to the review, the advisory committee is an important piece of it, but the advisory committee is not spending time with the patient level date of the review teams are. there are aspects where the advisory committee is not always engaged in, but we value their input and take their input seriously and try to engage subject matter experts to the greatest degree we can. >> the only reason i noticed this one is it was improved in 30 other jurisdictions already using the same datasets so those other jurisdictions are considered wrong too.
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that is a decision the fda can make and we managed to keep it safe. my time has run out. would you care to ask another question? >> it would be your turn. >> i know but go ahead. >> the fda is under way in its implementation of the generic drug user fee and it is my understanding that not all first generic applications have been approved the same day of the patent exploration. is there a reason for that? >> this is a program that as i thank you know, that is a big part of why the user fee program was begun with the passage of fdasia. we are moving forward in implementing that and addressing
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the backlog in critical ways and importantly also addressing the issues of expanding our in special capacity so that we can do those critical inspections. we are not where we need to be yet but we are committed to moving forward and we have made progress but there's a lot more work to be done. >> i will submit additional information i would like, how many applications the agency received for the first generic products and how many missed the approval of the earliest possible date and what you are doing for generic applications that are reviewed so that comes in more detail. thank you for being here today to answer our questions. we don't get this opportunity very often and you have done an
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outstanding job. >> thank you, senator enzi. when we did the reauthorization of user fees, for this committee, to make sure the devices, the 5-10 process approved for the 5-10 k process didn't have to go back to the agency everytime, in significant change is made to the device such as the color of the label or packaging has changed and i know just recently fda sent the 510 k modifications record to congress and i wanted to congratulate you on that and try and do stint fda held a public meeting in advance of preparing the report, engage in a healthy dialogue with interested parties. i appreciate all you did to work
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with the industry again. this is about working with the industry and in this case developed a report. again, it is another great example of fda industry collaboration and communication. what have you learned from the industry as a result of this collaboration? as you prepare the draft guidance on this topic which i understand to be the next step do you anticipate this sort of fda industry collaboration will continue? >> this kind of collaboration is key. i would add patience as well because at the end they our goal is to provide the best medical devices for there needs. but i think it has been very valuable in helping us to better understand the way in which this industry works. as you well know, it is not
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1-size-fits-all industry in terms of very small device companies and much larger device companies with very different needs and experience. the range of device product expanded rapidly and getting more complex. we do need to work together to keep progress moving forward and ultimately deliver what patients need, but we have -- i wouldn't say the interactions iec, but it has been very valuable to listen and learn and we try to be as responsive as possible and it is making a difference. >> they shouldn't necessarily
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always be. work with senator alexandra provision that would create new medical device companies that develop products, to treat rare conditions. in your written testimony that you approved five new products under our provision, thank you again for your work. can you explain why is so important to reward innovators for developing products to treat rare conditions? in this case, it was rare conditions that adults have. if those rare conditions were already a treatment for pediatric use that had already been approved, can you talk about why it is important to have these incentives? >> it is very important that we have the right incentives to get
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companies to invest in developing technologies where there may not be a huge marketplace, where the return on investment was not necessarily clear but where there is essential medical needs and where these products really will matter in addressing an individual pediatric patient or adult patients medical needs and requirements. we see this on a device side, on the drug side, that you cannot always assumed these important health care and public health needs will be addressed without looking at what are the opportunities, what are the barriers and are there incentives to help ensure that work goes on in these key often underaddressed areas. >> i am glad we had success on
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these products. senator enzi? any more questions? great. then thank you, dr. hamburg, for your testimony at your service. this hearing is adjourned. >> thank you so much. [inaudible conversations] [inaudible conversations] >> we are here at the state library archives in florida, the middle of three stacks floors at the archives. what you see behind you is a cubic foot box.
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of those 45,000 cubic feet you have 45,000 cubic feet of state records from the legislative branch of government, judicial and executive branch. yet 15,000 cubic feet of records that fall under our manuscript collection. private donations from individuals, everything from letters and journals to photographic collections. this is what is known as the patriot constitution of 1812. there is a lot of history behind this particular document. in 1812, a group of georgia settlers known as the patriot army invaded northeastern florida and were operating with the assistance of citizens living in spanish florida. at that time florida was still a colony of spain and the motivation for this group of individuals was they were going to come in to florida, they were primarily from georgia, they were going to come in to georgia and encourage the citizens of spanish florida to rise up against their government and
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proclaim independence. >> this weekend booktv and american history tv look at the history of literary life of florida's state capital, tallahassee. today at noon eastern on c-span2 and sunday at 2:00 on c-span3. you are watching booktv on c-span2, 48 hours of nonfiction authors and books. this weekend jonathan allen and amy partis discuss their book h r c:state secrets and the rebirth of hillary clinton followed by washington d.c. party of market's release. on our afterwards program george nash and eddie sleighs discuss the ideology of herbert hoover. ..


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